NCT06037395View on ClinicalTrials.gov

Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

154

Participants

Timeline

Start Date

October 6, 2021

Primary Completion Date

October 20, 2022

Study Completion Date

October 20, 2022

Conditions
Healthy Subject
Interventions
BIOLOGICAL

CT-P41

a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)

BIOLOGICAL

US-licensed Prolia

a single 60 mg subcutaneous (SC) injection via pre-filled syringe (PFS)

Trial Locations (2)

13520

CHA Bundang Medical Center, Seongnam

35015

Chungnam National University Hospital, Daejeon

Sponsors

Lead Sponsor

Celltrion
All Listed Sponsors
lead

Celltrion

INDUSTRY

NCT06037395 - Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects | Biotech Hunter | Biotech Hunter